AstraZeneca, FDA and breast cancer

US FDA approves AstraZeneca's drug for breast cancer
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of breast cancer, the health regulator said on Friday. The treatment, jointly developed with the Japanese company,
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
AstraZeneca’s Datroway approved in U.S. for HER2-negative breast cancer patients
DXd, has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
US FDA approves Amgen's colorectal cancer therapy
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients with a specific gene mutation.
AstraZeneca Gets FDA Approval for Metastatic Breast Cancer Treatment Datroway
AstraZeneca said the U.S. Food and Drug Administration approved Datroway, a treatment for metastatic breast cancer developed in combination with Daiichi Sankyo. The Anglo-Swedish drugmaker on Friday said that the approval is for adult breast cancer patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
FiercePharma2d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
FDA 'Closely Monitoring' Zyn Nicotine Pouches After Marketing Approval
The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but ...
The American Journal of Managed Care2d
FDA Grants 2 Traditional Approvals for Acalabrutinib
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
FiercePharma9d
Breaking down the 55 new drug approvals of 2024
A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods g | ...
MedPage Today3d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...
HealthDay on MSN2d
FDA Approves Omvoh for Moderately to Severely Active Crohn Disease
The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to sever ...
ConsumerAffairs2d
FDA approves 20 ZYN nicotine pouches after thorough' safety review
The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a ...
For first time, FDA approves marketing of nicotine pouch products
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an ...
Ozempic, Wegovy among drugs selected for Medicare's price negotiations
The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...
Becker's Hospital Review3d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...